SlideShare a Scribd company logo
1 of 16
P R E S E N TAT I O N S


T E C H N O L O G I C A L S T R AT E G I E S :
THE LAST LINE OF DEFENSE

A N T H O N Y J . D E S T E FA N O , P H . D .
S R . V I C E P R E S I D E N T,
COMPENDIAL SCIENCE
U N I T E D S TAT E S P H A R M AC O P E I A
SEPTEMBER 28, 2012
N AT I O N A L P R E S S C L U B
WWW.SAFEMEDICINES.ORG
Technological Strategies: The Last
        Line of Defense

        Anthony J. DeStefano, Ph.D.
  Sr. Vice President, Compendial Science
        United States Pharmacopeia
A Global Problem Requiring Global Solutions


   About 80% of all API made outside the US
   Similar trends in Drug Product manufacturing
   Detection of counterfeit or substandard products
    often impossible to detect visually – need a
    technical solution
   Solutions need to be standardized to facilitate rapid
    global transfer and adoption
   What are the roles of industry, government and the
    pharmacopeia?
    – How can we work synergistically and avoid duplication of
      effort?
                                                                 3
Industry – Counterfeit vs. Substandard

   Industry needs the most sophisticated and specialized
    technology
   Manufacturers must deal with
    – Sub-standard materials
    – Reverse-engineered nearly identical copies
   The latter require specialized tools
    – Specialized microscopy to assess if the die used in the tablet
      manufacture was one used by the company
    – Examination of impurity profiles of API and excipients to correlate with
      known sources of materials
   The former are also difficult – can’t be everywhere – how
    do you find the material and stop its manufacture?

                                                                           4
Governments - Standardization


   Can help drive standardization
    – Unified track and trace in the US
    – Reach out globally to standardize
   Need to target a solution that really addresses the
    issue
    – Is tracking at the lot level sufficient or a burden that still leaves a
      gap?
    – Is tracking at the unit level feasible in a short time frame?
   Need to develop a compelling global case that the
    gain is worth the pain


                                                                         5
Governments – Broad Reach


   How does one find counterfeits?
   Tools good enough to rapidly say “hold to assess
    authenticity”
   Sufficient people/equipment to check materials
    entering the country
    – Very small percentage checked now
    – Can’t stop the problem if we can’t detect it
   Technology needs to be standardized, portable,
    inexpensive and readily available


                                                       6
Examples of Tools Available

   Track and trace technology (e.g., bar code readers)
   Infrared spectroscopy (mid and near IR)
   Portable NMR
   Portable GC-MS
   Portable x-ray diffraction
   Microscopes
   HPLC and other traditional testing equipment



                                                      7
The Need for Standardization

   Identification/verification tools are critical
   Only as good as the standards against which the
    material is tested
   What does good look like, and how do you know?
   What is a “close enough” match with the database?
   How do you minimize false positives (manufacturer
    risks) and false negatives (consumer risks)?
   Answers require standardization and industry,
    governments and perhaps standard-setting bodies
    working together
                                                      8
Spectral Libraries – The Need for Standardization

   Spectral libraries (fingerprints against which the
    material in question is matched) are no better than
    the materials and methodology with which they are
    constructed
   Materials and products vary
    – Lot-to-lot differences (impurities, variations in formulation,
      uniformity of manufacture)
    – Regional differences (formulations for US, Africa,…)
    – Changes during the shelf life of a product
   Methodology varies
    – Sampling strategies
    – Protocols for obtaining spectra
    – Different manufacturers of the same technology – platform and
      data analysis differences                                  9
A Role for the Pharmacopeia?

   USP currently has access to nearly 3000 drug
    substance and drug product reference materials
   USP has a global presence, is used in over 140
    countries and has worked with many government
    across the globe
   As an independent third party, USP can provide
    confidentiality and global reach
   Combined with industry and government efforts, may
    be able to increase the “sets of eyes” out looking for
    counterfeits
   May be able to provide some of the standardization
    needed to make the current tools more effective
                                                       10
USING ADVANCED TECHNOLOGIES TO STOP COUNTERFEITERS


                                    Handheld Raman




                   Portable GC-MS
                                                       Portable NMR




Handheld XRF




 GS1 Handheld
 Barcode Scanner



                                    Portable NIR-MSP              Handheld NIR
12
USP Spectral Library Development Process


                    Materials        Method                          Data
 Instrument                                           Data
                   Acquisition,   Development
Acquisition &                      (Attributes,
                                                   Acquisition &   Analysis &
                    Storage &
  Validation        Retention     DoE, Analyzer)    Validation     Validation




                USP Quality Assurance SEAL (CoA & SOP)



            Global Public
                                  Education            Technical
             Awareness
                                   Training             Services
            & Promotion
NASA USING SPECTRAL LIBRARY TO DETECT MINERAL
COMPOSITION ON MARS




                                                14
Summary

   Counterfeiters are many and sophisticated so the people
    and equipment trying to stop them need to be as well
   Standardization is critical to speed and accuracy
    – Minimize false positives or false negatives
   Coordination of efforts is critical
    – Avoid duplication of effort
    – Avoid missed opportunities to apply technology
    – Avoid gaps in technology and optimize coverage
   Technological strategies, in all their manifestations, are
    critical to success
   The public expects us to succeed - we need to provide
    them with the protection they expect and deserve
                                                                 15
Technological Strategies: The Last Line of Defense Against Counterfeit Medicines

More Related Content

Viewers also liked

Supply Chain Integrity: The Patient Care Interface by David Chen, The Society...
Supply Chain Integrity: The Patient Care Interface by David Chen, The Society...Supply Chain Integrity: The Patient Care Interface by David Chen, The Society...
Supply Chain Integrity: The Patient Care Interface by David Chen, The Society...The Partnership For Safe Medicines
 
"Counterfeit Medicines: Threat to Public Health and Safety," Congressional Br...
"Counterfeit Medicines: Threat to Public Health and Safety," Congressional Br..."Counterfeit Medicines: Threat to Public Health and Safety," Congressional Br...
"Counterfeit Medicines: Threat to Public Health and Safety," Congressional Br...The Partnership For Safe Medicines
 
PSM Interchange 2014 Panel 3: Daniel Burke: The Impacts of Fake Online Pharma...
PSM Interchange 2014 Panel 3: Daniel Burke: The Impacts of Fake Online Pharma...PSM Interchange 2014 Panel 3: Daniel Burke: The Impacts of Fake Online Pharma...
PSM Interchange 2014 Panel 3: Daniel Burke: The Impacts of Fake Online Pharma...The Partnership For Safe Medicines
 
PSM Interchange 2014: Scott LaGanga, Welcome to the 2014 Interchange
PSM Interchange 2014: Scott LaGanga, Welcome to the 2014 InterchangePSM Interchange 2014: Scott LaGanga, Welcome to the 2014 Interchange
PSM Interchange 2014: Scott LaGanga, Welcome to the 2014 InterchangeThe Partnership For Safe Medicines
 
PSM Interchange 2014: Madame Lihong Gu, Partnership for Safe Medicines, China
PSM Interchange 2014: Madame Lihong Gu, Partnership for Safe Medicines, ChinaPSM Interchange 2014: Madame Lihong Gu, Partnership for Safe Medicines, China
PSM Interchange 2014: Madame Lihong Gu, Partnership for Safe Medicines, ChinaThe Partnership For Safe Medicines
 
Panel 4 - Linda Marks Senior Counsel: Overview of New Developments in Interna...
Panel 4 - Linda Marks Senior Counsel: Overview of New Developments in Interna...Panel 4 - Linda Marks Senior Counsel: Overview of New Developments in Interna...
Panel 4 - Linda Marks Senior Counsel: Overview of New Developments in Interna...The Partnership For Safe Medicines
 
PSM Interchange 2014: Tim Mackey, After Avastin: What Have We Learned, What C...
PSM Interchange 2014: Tim Mackey, After Avastin: What Have We Learned, What C...PSM Interchange 2014: Tim Mackey, After Avastin: What Have We Learned, What C...
PSM Interchange 2014: Tim Mackey, After Avastin: What Have We Learned, What C...The Partnership For Safe Medicines
 
PSM Interchange 2014 Panel 1: Tom Kubic, Global Trends Situation Report 2013
PSM Interchange 2014 Panel 1: Tom Kubic, Global Trends Situation Report 2013PSM Interchange 2014 Panel 1: Tom Kubic, Global Trends Situation Report 2013
PSM Interchange 2014 Panel 1: Tom Kubic, Global Trends Situation Report 2013The Partnership For Safe Medicines
 
PSM Interchange 2014 Panel 3: Todd Brown: Non-FDA Approved Foreign Drugs Are ...
PSM Interchange 2014 Panel 3: Todd Brown: Non-FDA Approved Foreign Drugs Are ...PSM Interchange 2014 Panel 3: Todd Brown: Non-FDA Approved Foreign Drugs Are ...
PSM Interchange 2014 Panel 3: Todd Brown: Non-FDA Approved Foreign Drugs Are ...The Partnership For Safe Medicines
 
The UK (MHRA) approach to combating Falsified Medicines by Gerald Heddell, MHRA
The UK (MHRA) approach to combating Falsified Medicines by Gerald Heddell, MHRAThe UK (MHRA) approach to combating Falsified Medicines by Gerald Heddell, MHRA
The UK (MHRA) approach to combating Falsified Medicines by Gerald Heddell, MHRAThe Partnership For Safe Medicines
 
Panel 2 Moderated by Dr. Bryan Liang Overview of Fake Online Pharmacy Issues
Panel 2 Moderated by Dr. Bryan Liang Overview of Fake Online Pharmacy IssuesPanel 2 Moderated by Dr. Bryan Liang Overview of Fake Online Pharmacy Issues
Panel 2 Moderated by Dr. Bryan Liang Overview of Fake Online Pharmacy IssuesThe Partnership For Safe Medicines
 
Americans patients exposed to counterfeit and black market medication
Americans patients exposed to counterfeit and black market medicationAmericans patients exposed to counterfeit and black market medication
Americans patients exposed to counterfeit and black market medicationThe Partnership For Safe Medicines
 
PSM Interchange 2014: Marv Shepherd, United State Pharmacopeia Good Distribut...
PSM Interchange 2014: Marv Shepherd, United State Pharmacopeia Good Distribut...PSM Interchange 2014: Marv Shepherd, United State Pharmacopeia Good Distribut...
PSM Interchange 2014: Marv Shepherd, United State Pharmacopeia Good Distribut...The Partnership For Safe Medicines
 
"Protecting Patients from Counterfeit Medicines," Congressional Briefing, Mar...
"Protecting Patients from Counterfeit Medicines," Congressional Briefing, Mar..."Protecting Patients from Counterfeit Medicines," Congressional Briefing, Mar...
"Protecting Patients from Counterfeit Medicines," Congressional Briefing, Mar...The Partnership For Safe Medicines
 

Viewers also liked (17)

Supply Chain Integrity: The Patient Care Interface by David Chen, The Society...
Supply Chain Integrity: The Patient Care Interface by David Chen, The Society...Supply Chain Integrity: The Patient Care Interface by David Chen, The Society...
Supply Chain Integrity: The Patient Care Interface by David Chen, The Society...
 
"Counterfeit Medicines: Threat to Public Health and Safety," Congressional Br...
"Counterfeit Medicines: Threat to Public Health and Safety," Congressional Br..."Counterfeit Medicines: Threat to Public Health and Safety," Congressional Br...
"Counterfeit Medicines: Threat to Public Health and Safety," Congressional Br...
 
PSM Interchange 2014 Panel 3: Daniel Burke: The Impacts of Fake Online Pharma...
PSM Interchange 2014 Panel 3: Daniel Burke: The Impacts of Fake Online Pharma...PSM Interchange 2014 Panel 3: Daniel Burke: The Impacts of Fake Online Pharma...
PSM Interchange 2014 Panel 3: Daniel Burke: The Impacts of Fake Online Pharma...
 
PSM Interchange 2014: Scott LaGanga, Welcome to the 2014 Interchange
PSM Interchange 2014: Scott LaGanga, Welcome to the 2014 InterchangePSM Interchange 2014: Scott LaGanga, Welcome to the 2014 Interchange
PSM Interchange 2014: Scott LaGanga, Welcome to the 2014 Interchange
 
PSM Interchange 2014: Madame Lihong Gu, Partnership for Safe Medicines, China
PSM Interchange 2014: Madame Lihong Gu, Partnership for Safe Medicines, ChinaPSM Interchange 2014: Madame Lihong Gu, Partnership for Safe Medicines, China
PSM Interchange 2014: Madame Lihong Gu, Partnership for Safe Medicines, China
 
Panel 4 - Linda Marks Senior Counsel: Overview of New Developments in Interna...
Panel 4 - Linda Marks Senior Counsel: Overview of New Developments in Interna...Panel 4 - Linda Marks Senior Counsel: Overview of New Developments in Interna...
Panel 4 - Linda Marks Senior Counsel: Overview of New Developments in Interna...
 
PSM Interchange 2014: Tim Mackey, After Avastin: What Have We Learned, What C...
PSM Interchange 2014: Tim Mackey, After Avastin: What Have We Learned, What C...PSM Interchange 2014: Tim Mackey, After Avastin: What Have We Learned, What C...
PSM Interchange 2014: Tim Mackey, After Avastin: What Have We Learned, What C...
 
PSM Interchange 2014 Panel 1: Tom Kubic, Global Trends Situation Report 2013
PSM Interchange 2014 Panel 1: Tom Kubic, Global Trends Situation Report 2013PSM Interchange 2014 Panel 1: Tom Kubic, Global Trends Situation Report 2013
PSM Interchange 2014 Panel 1: Tom Kubic, Global Trends Situation Report 2013
 
PSM Interchange 2014 Panel 3: Todd Brown: Non-FDA Approved Foreign Drugs Are ...
PSM Interchange 2014 Panel 3: Todd Brown: Non-FDA Approved Foreign Drugs Are ...PSM Interchange 2014 Panel 3: Todd Brown: Non-FDA Approved Foreign Drugs Are ...
PSM Interchange 2014 Panel 3: Todd Brown: Non-FDA Approved Foreign Drugs Are ...
 
The UK (MHRA) approach to combating Falsified Medicines by Gerald Heddell, MHRA
The UK (MHRA) approach to combating Falsified Medicines by Gerald Heddell, MHRAThe UK (MHRA) approach to combating Falsified Medicines by Gerald Heddell, MHRA
The UK (MHRA) approach to combating Falsified Medicines by Gerald Heddell, MHRA
 
Panel 2 Moderated by Dr. Bryan Liang Overview of Fake Online Pharmacy Issues
Panel 2 Moderated by Dr. Bryan Liang Overview of Fake Online Pharmacy IssuesPanel 2 Moderated by Dr. Bryan Liang Overview of Fake Online Pharmacy Issues
Panel 2 Moderated by Dr. Bryan Liang Overview of Fake Online Pharmacy Issues
 
Americans patients exposed to counterfeit and black market medication
Americans patients exposed to counterfeit and black market medicationAmericans patients exposed to counterfeit and black market medication
Americans patients exposed to counterfeit and black market medication
 
Counterfeit Drug Infographics for Interchange 2013
Counterfeit Drug Infographics for Interchange 2013Counterfeit Drug Infographics for Interchange 2013
Counterfeit Drug Infographics for Interchange 2013
 
PSM Interchange 2014 Panel 3: Kenneth 'Mac' McCall
PSM Interchange 2014 Panel 3: Kenneth 'Mac' McCallPSM Interchange 2014 Panel 3: Kenneth 'Mac' McCall
PSM Interchange 2014 Panel 3: Kenneth 'Mac' McCall
 
Counterfeit drugs 101 for Healthcare Providers
Counterfeit drugs 101 for Healthcare ProvidersCounterfeit drugs 101 for Healthcare Providers
Counterfeit drugs 101 for Healthcare Providers
 
PSM Interchange 2014: Marv Shepherd, United State Pharmacopeia Good Distribut...
PSM Interchange 2014: Marv Shepherd, United State Pharmacopeia Good Distribut...PSM Interchange 2014: Marv Shepherd, United State Pharmacopeia Good Distribut...
PSM Interchange 2014: Marv Shepherd, United State Pharmacopeia Good Distribut...
 
"Protecting Patients from Counterfeit Medicines," Congressional Briefing, Mar...
"Protecting Patients from Counterfeit Medicines," Congressional Briefing, Mar..."Protecting Patients from Counterfeit Medicines," Congressional Briefing, Mar...
"Protecting Patients from Counterfeit Medicines," Congressional Briefing, Mar...
 

Similar to Technological Strategies: The Last Line of Defense Against Counterfeit Medicines

A Radio Frequency Identification (RFID)-based wireless sensor device for drug...
A Radio Frequency Identification (RFID)-based wireless sensor device for drug...A Radio Frequency Identification (RFID)-based wireless sensor device for drug...
A Radio Frequency Identification (RFID)-based wireless sensor device for drug...Health Informatics New Zealand
 
Adequate directions for use "In the Age of AI and Watson"
Adequate directions for use "In the Age of AI and Watson"Adequate directions for use "In the Age of AI and Watson"
Adequate directions for use "In the Age of AI and Watson"Stephen Allan Weitzman
 
Moore_Rice Bioentrepeneurship_Tech Assess (LI)
Moore_Rice Bioentrepeneurship_Tech Assess (LI)Moore_Rice Bioentrepeneurship_Tech Assess (LI)
Moore_Rice Bioentrepeneurship_Tech Assess (LI)Jason Moore, MS, MBA, RAC
 
Moore Tech Assess April 2009 (L)
Moore Tech Assess April 2009 (L)Moore Tech Assess April 2009 (L)
Moore Tech Assess April 2009 (L)jmoore89
 
1 agilent solutions in pharmaceuticals
1 agilent solutions in pharmaceuticals1 agilent solutions in pharmaceuticals
1 agilent solutions in pharmaceuticalsDonnyRahmanKhalik1
 
Identifying Safety Signals by Data Mining the FDA Adverse Event Reporting Sys...
Identifying Safety Signals by Data Mining the FDA Adverse Event Reporting Sys...Identifying Safety Signals by Data Mining the FDA Adverse Event Reporting Sys...
Identifying Safety Signals by Data Mining the FDA Adverse Event Reporting Sys...Perficient, Inc.
 
Quantitative signal detection for the mid sized pharma - webcast
Quantitative signal detection for the mid sized pharma - webcastQuantitative signal detection for the mid sized pharma - webcast
Quantitative signal detection for the mid sized pharma - webcastpharmasol
 
Fao Presentation 31 3 2008 To Tanzania Surveillance Workshop
Fao Presentation 31 3 2008 To Tanzania Surveillance WorkshopFao Presentation 31 3 2008 To Tanzania Surveillance Workshop
Fao Presentation 31 3 2008 To Tanzania Surveillance Workshopemilymeasures
 
Western blotting market
Western blotting marketWestern blotting market
Western blotting marketShrutiKarhekar
 
Pistoia Alliance Debates: Clinical trials and wearables, 21st Jan 2016
Pistoia Alliance Debates: Clinical trials and wearables, 21st Jan 2016Pistoia Alliance Debates: Clinical trials and wearables, 21st Jan 2016
Pistoia Alliance Debates: Clinical trials and wearables, 21st Jan 2016Pistoia Alliance
 
Competitive landsape by Clarivate Analytics
Competitive landsape by Clarivate AnalyticsCompetitive landsape by Clarivate Analytics
Competitive landsape by Clarivate AnalyticsSam Nixon
 
ICWES15 - Medical Devices - Partnering for Success. Presented by Prof Karen R...
ICWES15 - Medical Devices - Partnering for Success. Presented by Prof Karen R...ICWES15 - Medical Devices - Partnering for Success. Presented by Prof Karen R...
ICWES15 - Medical Devices - Partnering for Success. Presented by Prof Karen R...Engineers Australia
 
IEEE augmented reality learning experience model (ARLEM)
IEEE augmented reality learning experience model (ARLEM)IEEE augmented reality learning experience model (ARLEM)
IEEE augmented reality learning experience model (ARLEM)fridolin.wild
 
Snap shot lever 2019 website version
Snap shot   lever 2019 website versionSnap shot   lever 2019 website version
Snap shot lever 2019 website versionkphodel
 
Pistoia Alliance Debates: IDMP: It’s all about the patient: enhancing patient...
Pistoia Alliance Debates: IDMP: It’s all about the patient: enhancing patient...Pistoia Alliance Debates: IDMP: It’s all about the patient: enhancing patient...
Pistoia Alliance Debates: IDMP: It’s all about the patient: enhancing patient...Pistoia Alliance
 
Giab aug2015 intro and update 150821.pptx
Giab aug2015 intro and update 150821.pptxGiab aug2015 intro and update 150821.pptx
Giab aug2015 intro and update 150821.pptxGenomeInABottle
 
Organs-On-Chips - 2017 Report by Yole Developpement
Organs-On-Chips - 2017 Report by Yole DeveloppementOrgans-On-Chips - 2017 Report by Yole Developpement
Organs-On-Chips - 2017 Report by Yole DeveloppementYole Developpement
 

Similar to Technological Strategies: The Last Line of Defense Against Counterfeit Medicines (20)

Best Practices for Promotional Content Review
Best Practices for Promotional Content ReviewBest Practices for Promotional Content Review
Best Practices for Promotional Content Review
 
A Radio Frequency Identification (RFID)-based wireless sensor device for drug...
A Radio Frequency Identification (RFID)-based wireless sensor device for drug...A Radio Frequency Identification (RFID)-based wireless sensor device for drug...
A Radio Frequency Identification (RFID)-based wireless sensor device for drug...
 
Adequate directions for use "In the Age of AI and Watson"
Adequate directions for use "In the Age of AI and Watson"Adequate directions for use "In the Age of AI and Watson"
Adequate directions for use "In the Age of AI and Watson"
 
Moore_Rice Bioentrepeneurship_Tech Assess (LI)
Moore_Rice Bioentrepeneurship_Tech Assess (LI)Moore_Rice Bioentrepeneurship_Tech Assess (LI)
Moore_Rice Bioentrepeneurship_Tech Assess (LI)
 
Moore Tech Assess April 2009 (L)
Moore Tech Assess April 2009 (L)Moore Tech Assess April 2009 (L)
Moore Tech Assess April 2009 (L)
 
1 agilent solutions in pharmaceuticals
1 agilent solutions in pharmaceuticals1 agilent solutions in pharmaceuticals
1 agilent solutions in pharmaceuticals
 
Identifying Safety Signals by Data Mining the FDA Adverse Event Reporting Sys...
Identifying Safety Signals by Data Mining the FDA Adverse Event Reporting Sys...Identifying Safety Signals by Data Mining the FDA Adverse Event Reporting Sys...
Identifying Safety Signals by Data Mining the FDA Adverse Event Reporting Sys...
 
Quantitative signal detection for the mid sized pharma - webcast
Quantitative signal detection for the mid sized pharma - webcastQuantitative signal detection for the mid sized pharma - webcast
Quantitative signal detection for the mid sized pharma - webcast
 
Fao Presentation 31 3 2008 To Tanzania Surveillance Workshop
Fao Presentation 31 3 2008 To Tanzania Surveillance WorkshopFao Presentation 31 3 2008 To Tanzania Surveillance Workshop
Fao Presentation 31 3 2008 To Tanzania Surveillance Workshop
 
Western blotting market
Western blotting marketWestern blotting market
Western blotting market
 
Pistoia Alliance Debates: Clinical trials and wearables, 21st Jan 2016
Pistoia Alliance Debates: Clinical trials and wearables, 21st Jan 2016Pistoia Alliance Debates: Clinical trials and wearables, 21st Jan 2016
Pistoia Alliance Debates: Clinical trials and wearables, 21st Jan 2016
 
Competitive landsape by Clarivate Analytics
Competitive landsape by Clarivate AnalyticsCompetitive landsape by Clarivate Analytics
Competitive landsape by Clarivate Analytics
 
ICWES15 - Medical Devices - Partnering for Success. Presented by Prof Karen R...
ICWES15 - Medical Devices - Partnering for Success. Presented by Prof Karen R...ICWES15 - Medical Devices - Partnering for Success. Presented by Prof Karen R...
ICWES15 - Medical Devices - Partnering for Success. Presented by Prof Karen R...
 
PV 2016
PV 2016PV 2016
PV 2016
 
IEEE augmented reality learning experience model (ARLEM)
IEEE augmented reality learning experience model (ARLEM)IEEE augmented reality learning experience model (ARLEM)
IEEE augmented reality learning experience model (ARLEM)
 
Inserogen Lecture 4 Channels
Inserogen Lecture 4 ChannelsInserogen Lecture 4 Channels
Inserogen Lecture 4 Channels
 
Snap shot lever 2019 website version
Snap shot   lever 2019 website versionSnap shot   lever 2019 website version
Snap shot lever 2019 website version
 
Pistoia Alliance Debates: IDMP: It’s all about the patient: enhancing patient...
Pistoia Alliance Debates: IDMP: It’s all about the patient: enhancing patient...Pistoia Alliance Debates: IDMP: It’s all about the patient: enhancing patient...
Pistoia Alliance Debates: IDMP: It’s all about the patient: enhancing patient...
 
Giab aug2015 intro and update 150821.pptx
Giab aug2015 intro and update 150821.pptxGiab aug2015 intro and update 150821.pptx
Giab aug2015 intro and update 150821.pptx
 
Organs-On-Chips - 2017 Report by Yole Developpement
Organs-On-Chips - 2017 Report by Yole DeveloppementOrgans-On-Chips - 2017 Report by Yole Developpement
Organs-On-Chips - 2017 Report by Yole Developpement
 

More from The Partnership For Safe Medicines

Crime and Policy III: Partnership for Safe Medicines overview for 2021
Crime and Policy III: Partnership for Safe Medicines overview for 2021Crime and Policy III: Partnership for Safe Medicines overview for 2021
Crime and Policy III: Partnership for Safe Medicines overview for 2021The Partnership For Safe Medicines
 
The Partnership for Safe Medicines Congressional Briefing, September 24, 2019
The Partnership for Safe Medicines Congressional Briefing, September 24, 2019The Partnership for Safe Medicines Congressional Briefing, September 24, 2019
The Partnership for Safe Medicines Congressional Briefing, September 24, 2019The Partnership For Safe Medicines
 
Cartels and Counterfeits: International Organized Crime And Counterfeit Drugs
Cartels and Counterfeits: International Organized Crime And Counterfeit DrugsCartels and Counterfeits: International Organized Crime And Counterfeit Drugs
Cartels and Counterfeits: International Organized Crime And Counterfeit DrugsThe Partnership For Safe Medicines
 
"Problems with importing medicine from Canada" - webinar slides
"Problems with importing medicine from Canada" - webinar slides"Problems with importing medicine from Canada" - webinar slides
"Problems with importing medicine from Canada" - webinar slidesThe Partnership For Safe Medicines
 
Drug importation: Maine's Experience with Unreliable Foreign 'Pharmacies,' 20...
Drug importation: Maine's Experience with Unreliable Foreign 'Pharmacies,' 20...Drug importation: Maine's Experience with Unreliable Foreign 'Pharmacies,' 20...
Drug importation: Maine's Experience with Unreliable Foreign 'Pharmacies,' 20...The Partnership For Safe Medicines
 
"The Insidious Path of Counterfeit Cancer Drugs from Turkey to Toledo: How d...
"The Insidious Path of Counterfeit Cancer Drugs from Turkey to Toledo:  How d..."The Insidious Path of Counterfeit Cancer Drugs from Turkey to Toledo:  How d...
"The Insidious Path of Counterfeit Cancer Drugs from Turkey to Toledo: How d...The Partnership For Safe Medicines
 
PSM Interchange 2014 Panel 3, Libby Baney, The Impact of Fake Online Pharmac...
PSM Interchange 2014 Panel  3, Libby Baney, The Impact of Fake Online Pharmac...PSM Interchange 2014 Panel  3, Libby Baney, The Impact of Fake Online Pharmac...
PSM Interchange 2014 Panel 3, Libby Baney, The Impact of Fake Online Pharmac...The Partnership For Safe Medicines
 

More from The Partnership For Safe Medicines (12)

Family advocate webinar 2/2/2022
Family advocate webinar 2/2/2022Family advocate webinar 2/2/2022
Family advocate webinar 2/2/2022
 
Crime and Policy III: Partnership for Safe Medicines overview for 2021
Crime and Policy III: Partnership for Safe Medicines overview for 2021Crime and Policy III: Partnership for Safe Medicines overview for 2021
Crime and Policy III: Partnership for Safe Medicines overview for 2021
 
Cpha deck
Cpha deckCpha deck
Cpha deck
 
The Partnership for Safe Medicines Congressional Briefing, September 24, 2019
The Partnership for Safe Medicines Congressional Briefing, September 24, 2019The Partnership for Safe Medicines Congressional Briefing, September 24, 2019
The Partnership for Safe Medicines Congressional Briefing, September 24, 2019
 
Cartels and Counterfeits: International Organized Crime And Counterfeit Drugs
Cartels and Counterfeits: International Organized Crime And Counterfeit DrugsCartels and Counterfeits: International Organized Crime And Counterfeit Drugs
Cartels and Counterfeits: International Organized Crime And Counterfeit Drugs
 
“Can You Safely Implement Canadian Importation?
“Can You Safely Implement Canadian Importation?“Can You Safely Implement Canadian Importation?
“Can You Safely Implement Canadian Importation?
 
"Problems with importing medicine from Canada" - webinar slides
"Problems with importing medicine from Canada" - webinar slides"Problems with importing medicine from Canada" - webinar slides
"Problems with importing medicine from Canada" - webinar slides
 
NeedyMeds May 2017 webinar
NeedyMeds May 2017 webinarNeedyMeds May 2017 webinar
NeedyMeds May 2017 webinar
 
Counterfeit Drugs in America: 2017 Overview
Counterfeit Drugs in America: 2017 OverviewCounterfeit Drugs in America: 2017 Overview
Counterfeit Drugs in America: 2017 Overview
 
Drug importation: Maine's Experience with Unreliable Foreign 'Pharmacies,' 20...
Drug importation: Maine's Experience with Unreliable Foreign 'Pharmacies,' 20...Drug importation: Maine's Experience with Unreliable Foreign 'Pharmacies,' 20...
Drug importation: Maine's Experience with Unreliable Foreign 'Pharmacies,' 20...
 
"The Insidious Path of Counterfeit Cancer Drugs from Turkey to Toledo: How d...
"The Insidious Path of Counterfeit Cancer Drugs from Turkey to Toledo:  How d..."The Insidious Path of Counterfeit Cancer Drugs from Turkey to Toledo:  How d...
"The Insidious Path of Counterfeit Cancer Drugs from Turkey to Toledo: How d...
 
PSM Interchange 2014 Panel 3, Libby Baney, The Impact of Fake Online Pharmac...
PSM Interchange 2014 Panel  3, Libby Baney, The Impact of Fake Online Pharmac...PSM Interchange 2014 Panel  3, Libby Baney, The Impact of Fake Online Pharmac...
PSM Interchange 2014 Panel 3, Libby Baney, The Impact of Fake Online Pharmac...
 

Recently uploaded

My Hashitalk Indonesia April 2024 Presentation
My Hashitalk Indonesia April 2024 PresentationMy Hashitalk Indonesia April 2024 Presentation
My Hashitalk Indonesia April 2024 PresentationRidwan Fadjar
 
Kotlin Multiplatform & Compose Multiplatform - Starter kit for pragmatics
Kotlin Multiplatform & Compose Multiplatform - Starter kit for pragmaticsKotlin Multiplatform & Compose Multiplatform - Starter kit for pragmatics
Kotlin Multiplatform & Compose Multiplatform - Starter kit for pragmaticscarlostorres15106
 
GenCyber Cyber Security Day Presentation
GenCyber Cyber Security Day PresentationGenCyber Cyber Security Day Presentation
GenCyber Cyber Security Day PresentationMichael W. Hawkins
 
Install Stable Diffusion in windows machine
Install Stable Diffusion in windows machineInstall Stable Diffusion in windows machine
Install Stable Diffusion in windows machinePadma Pradeep
 
08448380779 Call Girls In Diplomatic Enclave Women Seeking Men
08448380779 Call Girls In Diplomatic Enclave Women Seeking Men08448380779 Call Girls In Diplomatic Enclave Women Seeking Men
08448380779 Call Girls In Diplomatic Enclave Women Seeking MenDelhi Call girls
 
How to Remove Document Management Hurdles with X-Docs?
How to Remove Document Management Hurdles with X-Docs?How to Remove Document Management Hurdles with X-Docs?
How to Remove Document Management Hurdles with X-Docs?XfilesPro
 
The Codex of Business Writing Software for Real-World Solutions 2.pptx
The Codex of Business Writing Software for Real-World Solutions 2.pptxThe Codex of Business Writing Software for Real-World Solutions 2.pptx
The Codex of Business Writing Software for Real-World Solutions 2.pptxMalak Abu Hammad
 
Artificial intelligence in the post-deep learning era
Artificial intelligence in the post-deep learning eraArtificial intelligence in the post-deep learning era
Artificial intelligence in the post-deep learning eraDeakin University
 
FULL ENJOY 🔝 8264348440 🔝 Call Girls in Diplomatic Enclave | Delhi
FULL ENJOY 🔝 8264348440 🔝 Call Girls in Diplomatic Enclave | DelhiFULL ENJOY 🔝 8264348440 🔝 Call Girls in Diplomatic Enclave | Delhi
FULL ENJOY 🔝 8264348440 🔝 Call Girls in Diplomatic Enclave | Delhisoniya singh
 
Unblocking The Main Thread Solving ANRs and Frozen Frames
Unblocking The Main Thread Solving ANRs and Frozen FramesUnblocking The Main Thread Solving ANRs and Frozen Frames
Unblocking The Main Thread Solving ANRs and Frozen FramesSinan KOZAK
 
Pigging Solutions in Pet Food Manufacturing
Pigging Solutions in Pet Food ManufacturingPigging Solutions in Pet Food Manufacturing
Pigging Solutions in Pet Food ManufacturingPigging Solutions
 
Hyderabad Call Girls Khairatabad ✨ 7001305949 ✨ Cheap Price Your Budget
Hyderabad Call Girls Khairatabad ✨ 7001305949 ✨ Cheap Price Your BudgetHyderabad Call Girls Khairatabad ✨ 7001305949 ✨ Cheap Price Your Budget
Hyderabad Call Girls Khairatabad ✨ 7001305949 ✨ Cheap Price Your BudgetEnjoy Anytime
 
08448380779 Call Girls In Greater Kailash - I Women Seeking Men
08448380779 Call Girls In Greater Kailash - I Women Seeking Men08448380779 Call Girls In Greater Kailash - I Women Seeking Men
08448380779 Call Girls In Greater Kailash - I Women Seeking MenDelhi Call girls
 
Snow Chain-Integrated Tire for a Safe Drive on Winter Roads
Snow Chain-Integrated Tire for a Safe Drive on Winter RoadsSnow Chain-Integrated Tire for a Safe Drive on Winter Roads
Snow Chain-Integrated Tire for a Safe Drive on Winter RoadsHyundai Motor Group
 
Key Features Of Token Development (1).pptx
Key  Features Of Token  Development (1).pptxKey  Features Of Token  Development (1).pptx
Key Features Of Token Development (1).pptxLBM Solutions
 
Benefits Of Flutter Compared To Other Frameworks
Benefits Of Flutter Compared To Other FrameworksBenefits Of Flutter Compared To Other Frameworks
Benefits Of Flutter Compared To Other FrameworksSoftradix Technologies
 
Next-generation AAM aircraft unveiled by Supernal, S-A2
Next-generation AAM aircraft unveiled by Supernal, S-A2Next-generation AAM aircraft unveiled by Supernal, S-A2
Next-generation AAM aircraft unveiled by Supernal, S-A2Hyundai Motor Group
 
IAC 2024 - IA Fast Track to Search Focused AI Solutions
IAC 2024 - IA Fast Track to Search Focused AI SolutionsIAC 2024 - IA Fast Track to Search Focused AI Solutions
IAC 2024 - IA Fast Track to Search Focused AI SolutionsEnterprise Knowledge
 
Understanding the Laravel MVC Architecture
Understanding the Laravel MVC ArchitectureUnderstanding the Laravel MVC Architecture
Understanding the Laravel MVC ArchitecturePixlogix Infotech
 

Recently uploaded (20)

My Hashitalk Indonesia April 2024 Presentation
My Hashitalk Indonesia April 2024 PresentationMy Hashitalk Indonesia April 2024 Presentation
My Hashitalk Indonesia April 2024 Presentation
 
Kotlin Multiplatform & Compose Multiplatform - Starter kit for pragmatics
Kotlin Multiplatform & Compose Multiplatform - Starter kit for pragmaticsKotlin Multiplatform & Compose Multiplatform - Starter kit for pragmatics
Kotlin Multiplatform & Compose Multiplatform - Starter kit for pragmatics
 
GenCyber Cyber Security Day Presentation
GenCyber Cyber Security Day PresentationGenCyber Cyber Security Day Presentation
GenCyber Cyber Security Day Presentation
 
Install Stable Diffusion in windows machine
Install Stable Diffusion in windows machineInstall Stable Diffusion in windows machine
Install Stable Diffusion in windows machine
 
08448380779 Call Girls In Diplomatic Enclave Women Seeking Men
08448380779 Call Girls In Diplomatic Enclave Women Seeking Men08448380779 Call Girls In Diplomatic Enclave Women Seeking Men
08448380779 Call Girls In Diplomatic Enclave Women Seeking Men
 
How to Remove Document Management Hurdles with X-Docs?
How to Remove Document Management Hurdles with X-Docs?How to Remove Document Management Hurdles with X-Docs?
How to Remove Document Management Hurdles with X-Docs?
 
The Codex of Business Writing Software for Real-World Solutions 2.pptx
The Codex of Business Writing Software for Real-World Solutions 2.pptxThe Codex of Business Writing Software for Real-World Solutions 2.pptx
The Codex of Business Writing Software for Real-World Solutions 2.pptx
 
Artificial intelligence in the post-deep learning era
Artificial intelligence in the post-deep learning eraArtificial intelligence in the post-deep learning era
Artificial intelligence in the post-deep learning era
 
FULL ENJOY 🔝 8264348440 🔝 Call Girls in Diplomatic Enclave | Delhi
FULL ENJOY 🔝 8264348440 🔝 Call Girls in Diplomatic Enclave | DelhiFULL ENJOY 🔝 8264348440 🔝 Call Girls in Diplomatic Enclave | Delhi
FULL ENJOY 🔝 8264348440 🔝 Call Girls in Diplomatic Enclave | Delhi
 
Unblocking The Main Thread Solving ANRs and Frozen Frames
Unblocking The Main Thread Solving ANRs and Frozen FramesUnblocking The Main Thread Solving ANRs and Frozen Frames
Unblocking The Main Thread Solving ANRs and Frozen Frames
 
Pigging Solutions in Pet Food Manufacturing
Pigging Solutions in Pet Food ManufacturingPigging Solutions in Pet Food Manufacturing
Pigging Solutions in Pet Food Manufacturing
 
Hyderabad Call Girls Khairatabad ✨ 7001305949 ✨ Cheap Price Your Budget
Hyderabad Call Girls Khairatabad ✨ 7001305949 ✨ Cheap Price Your BudgetHyderabad Call Girls Khairatabad ✨ 7001305949 ✨ Cheap Price Your Budget
Hyderabad Call Girls Khairatabad ✨ 7001305949 ✨ Cheap Price Your Budget
 
08448380779 Call Girls In Greater Kailash - I Women Seeking Men
08448380779 Call Girls In Greater Kailash - I Women Seeking Men08448380779 Call Girls In Greater Kailash - I Women Seeking Men
08448380779 Call Girls In Greater Kailash - I Women Seeking Men
 
Snow Chain-Integrated Tire for a Safe Drive on Winter Roads
Snow Chain-Integrated Tire for a Safe Drive on Winter RoadsSnow Chain-Integrated Tire for a Safe Drive on Winter Roads
Snow Chain-Integrated Tire for a Safe Drive on Winter Roads
 
E-Vehicle_Hacking_by_Parul Sharma_null_owasp.pptx
E-Vehicle_Hacking_by_Parul Sharma_null_owasp.pptxE-Vehicle_Hacking_by_Parul Sharma_null_owasp.pptx
E-Vehicle_Hacking_by_Parul Sharma_null_owasp.pptx
 
Key Features Of Token Development (1).pptx
Key  Features Of Token  Development (1).pptxKey  Features Of Token  Development (1).pptx
Key Features Of Token Development (1).pptx
 
Benefits Of Flutter Compared To Other Frameworks
Benefits Of Flutter Compared To Other FrameworksBenefits Of Flutter Compared To Other Frameworks
Benefits Of Flutter Compared To Other Frameworks
 
Next-generation AAM aircraft unveiled by Supernal, S-A2
Next-generation AAM aircraft unveiled by Supernal, S-A2Next-generation AAM aircraft unveiled by Supernal, S-A2
Next-generation AAM aircraft unveiled by Supernal, S-A2
 
IAC 2024 - IA Fast Track to Search Focused AI Solutions
IAC 2024 - IA Fast Track to Search Focused AI SolutionsIAC 2024 - IA Fast Track to Search Focused AI Solutions
IAC 2024 - IA Fast Track to Search Focused AI Solutions
 
Understanding the Laravel MVC Architecture
Understanding the Laravel MVC ArchitectureUnderstanding the Laravel MVC Architecture
Understanding the Laravel MVC Architecture
 

Technological Strategies: The Last Line of Defense Against Counterfeit Medicines

  • 1. P R E S E N TAT I O N S T E C H N O L O G I C A L S T R AT E G I E S : THE LAST LINE OF DEFENSE A N T H O N Y J . D E S T E FA N O , P H . D . S R . V I C E P R E S I D E N T, COMPENDIAL SCIENCE U N I T E D S TAT E S P H A R M AC O P E I A SEPTEMBER 28, 2012 N AT I O N A L P R E S S C L U B WWW.SAFEMEDICINES.ORG
  • 2. Technological Strategies: The Last Line of Defense Anthony J. DeStefano, Ph.D. Sr. Vice President, Compendial Science United States Pharmacopeia
  • 3. A Global Problem Requiring Global Solutions  About 80% of all API made outside the US  Similar trends in Drug Product manufacturing  Detection of counterfeit or substandard products often impossible to detect visually – need a technical solution  Solutions need to be standardized to facilitate rapid global transfer and adoption  What are the roles of industry, government and the pharmacopeia? – How can we work synergistically and avoid duplication of effort? 3
  • 4. Industry – Counterfeit vs. Substandard  Industry needs the most sophisticated and specialized technology  Manufacturers must deal with – Sub-standard materials – Reverse-engineered nearly identical copies  The latter require specialized tools – Specialized microscopy to assess if the die used in the tablet manufacture was one used by the company – Examination of impurity profiles of API and excipients to correlate with known sources of materials  The former are also difficult – can’t be everywhere – how do you find the material and stop its manufacture? 4
  • 5. Governments - Standardization  Can help drive standardization – Unified track and trace in the US – Reach out globally to standardize  Need to target a solution that really addresses the issue – Is tracking at the lot level sufficient or a burden that still leaves a gap? – Is tracking at the unit level feasible in a short time frame?  Need to develop a compelling global case that the gain is worth the pain 5
  • 6. Governments – Broad Reach  How does one find counterfeits?  Tools good enough to rapidly say “hold to assess authenticity”  Sufficient people/equipment to check materials entering the country – Very small percentage checked now – Can’t stop the problem if we can’t detect it  Technology needs to be standardized, portable, inexpensive and readily available 6
  • 7. Examples of Tools Available  Track and trace technology (e.g., bar code readers)  Infrared spectroscopy (mid and near IR)  Portable NMR  Portable GC-MS  Portable x-ray diffraction  Microscopes  HPLC and other traditional testing equipment 7
  • 8. The Need for Standardization  Identification/verification tools are critical  Only as good as the standards against which the material is tested  What does good look like, and how do you know?  What is a “close enough” match with the database?  How do you minimize false positives (manufacturer risks) and false negatives (consumer risks)?  Answers require standardization and industry, governments and perhaps standard-setting bodies working together 8
  • 9. Spectral Libraries – The Need for Standardization  Spectral libraries (fingerprints against which the material in question is matched) are no better than the materials and methodology with which they are constructed  Materials and products vary – Lot-to-lot differences (impurities, variations in formulation, uniformity of manufacture) – Regional differences (formulations for US, Africa,…) – Changes during the shelf life of a product  Methodology varies – Sampling strategies – Protocols for obtaining spectra – Different manufacturers of the same technology – platform and data analysis differences 9
  • 10. A Role for the Pharmacopeia?  USP currently has access to nearly 3000 drug substance and drug product reference materials  USP has a global presence, is used in over 140 countries and has worked with many government across the globe  As an independent third party, USP can provide confidentiality and global reach  Combined with industry and government efforts, may be able to increase the “sets of eyes” out looking for counterfeits  May be able to provide some of the standardization needed to make the current tools more effective 10
  • 11. USING ADVANCED TECHNOLOGIES TO STOP COUNTERFEITERS Handheld Raman Portable GC-MS Portable NMR Handheld XRF GS1 Handheld Barcode Scanner Portable NIR-MSP Handheld NIR
  • 12. 12
  • 13. USP Spectral Library Development Process Materials Method Data Instrument Data Acquisition, Development Acquisition & (Attributes, Acquisition & Analysis & Storage & Validation Retention DoE, Analyzer) Validation Validation USP Quality Assurance SEAL (CoA & SOP) Global Public Education Technical Awareness Training Services & Promotion
  • 14. NASA USING SPECTRAL LIBRARY TO DETECT MINERAL COMPOSITION ON MARS 14
  • 15. Summary  Counterfeiters are many and sophisticated so the people and equipment trying to stop them need to be as well  Standardization is critical to speed and accuracy – Minimize false positives or false negatives  Coordination of efforts is critical – Avoid duplication of effort – Avoid missed opportunities to apply technology – Avoid gaps in technology and optimize coverage  Technological strategies, in all their manifestations, are critical to success  The public expects us to succeed - we need to provide them with the protection they expect and deserve 15

Editor's Notes

  1. Looking at rocks and soils from a distance, ChemCam on Mars Rover will fire a laser and analyze the elemental composition of vaporized materials from areas smaller than 1 millimeter on the surface of Martian rocks and soils. An on-board spectrograph, with a spectral library, will provide unprecedented detail about minerals and microstructures in rocks by measuring the composition of the resulting plasma -- an extremely hot gas made of free-floating ions and electrons.From 23 feet (7 meters) away, ChemCam will be able to: Rapidly identify the kind of rock being studied (for example, whether it is volcanic or sedimentary); Determine the composition of soils and pebbles; Measure the abundance of all chemical elements, including trace elements and those that might be hazardous to humans; Recognize ice and minerals with water molecules in their crystal structures; Measure the depth and composition of weathering rinds on rocks; and, Provide visual assistance during drilling of rock cores.The rover can send spectral information directly to Earth, it can also uplink information to other spacecraft orbiting Mars.